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Completed

NCT Number: NCT02943759

Resolution of Pain and Swelling After the Use of Neem Leaf Extract Compared to Chlorhexidine Gluconate as an Intracanal Irrigant During Pulpectomy

The trial is to test the resolution of pain, swelling and other signs of periapical infection and the antimicrobial efficacy when using the neem leaf extract compared to chlorhexidine as root canal irrigant in Pulpectomy treatment for children.

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Key information

Age range

4 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Pediatric dentistry and Public health department-Cairo University

Cairo, Egypt

About this study

To compare the effectiveness of neem leaf extract with that of Chlorhexidine gluconate when used as an intracanal irrigant in primary molar teeth indicated for pulpectomy treatment.

P: children with primary necrotic molars indicated for pulpectomy I: Neem leaf extract (alcoholic solution). C: 2% chlorhexidine gluconate. O: Pain and swelling resolution. T:Over 12 months. S: Randomised controlled trial.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient and parent cooperation.
  • Absence of any systemic disease that would contraindicate pulp therapy.
  • Non vital molar teeth presenting with an acute or chronic periapical infection as a result of pulp necrosis ( Periapical abscess ,a sinus tract formation as a sequelae )
  • Making sure the patient is not taking an antibiotic and has not taken it for the past 2 weeks.
  • Absence of physiologic or pathologic root resorption that contraindicate pulp therapy.
  • Restorable teeth
  • Molars with at least two thirds of root remaining.

Exclusion criteria

  • Children with any condition that contraindicates pulp therapy will be excluded (rheumatic fever, infective endocarditis , leukemia , corticosteroid therapy and immunosuppressed children).

Treatment and study plan

Neem leaf extract

Drug

A natural irrigant solution act as anti-inflammatory and anti bacterial

Chlorhexidine gluconate

Drug

2%chlorhexidine gluconate , anti bacterial root canal irrigant solution

Other names: Gluconate-Chex 2%

Primary outcomes

  1. Pain

    Time frame: 1 year

    Patient reported pain and pain on percussion , binary

  2. Swelling

    Time frame: 1 year

    Visual examination ,binary

  3. Mobility

    Time frame: 1 year

    Mobility test ,binary

Secondary outcomes

  1. Bacterial load

    Time frame: 48 hours

    Bacteria on culture plates measuring unit CFU/ml

  2. Periapical pathosis

    Time frame: 1 year

    Periapical radiograph , binary

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Resolution of Pain and Swelling After the Use of Neem Leaf Extract (Azadirachta Indica) Compared to Chlorhexidine Gluconate as an Intracanal Irrigant in Necrotic Primary Molar Teeth in Children Undergoing Pulpectomy Treatment: A Randomised Controlled Trial

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Oct 25, 2016
Registry last updated
Jul 31, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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